Weekly Paclitaxel-carboplatin As Front-line Chemotherapy In Elderly Patients With Locally Advanced/metastatic (stage Iiib-iv) Non-small-cell Lung Cancer. A Phase Ii Study

Background: Cisplatin-based regimens represent the standard chemotherapy in locally advanced/metastatic NSCLC. The presence of various comorbidities and/or renal impairment makes elderly patients poor candidates for such therapies. Several studies reported a better profile of tolerability for weekly infusion of paclitaxel (P) and/or carboplatin (Cb). The aim of this phase II study was to confirm the activity and feasibility of weekly P–Cb in elderly patients with locally advanced/metastatic NSCLC. Patients and methods: From May 2002 to December 2003 we consecutively recruited 18 ‘chemo-naive’ elderly pts with advanced NSCLC. The main characteristics of pts were: M12:F6, adenocarcinoma 8/18, epidermoidal 10/18, stage IIIB 6/18, stage IV 12/18, ECOG PS 0–1 (10/18), 2 (8/18), ADL/IADL dependent 6/18 pts. Pts received P 80 mg/m 2 plus Cb AUC2 weekly for three consecutive weeks every 28 days. A total of 75 cycles was delivered and every patient received at least two cycles of chemotherapy (range: 2–6). Results: All 18 pts were evaluable for response and toxicity. No complete responses were registered. Seven pts (38%) showed PR, five pts (27%) SD for a disease control rate (DCR) of 65%, six pts (33%) progressed. Median duration of response was 88.6 days (range 31–146), median overall survival (months): 9.3 (4.3–13.4). Toxicity was globally acceptable: G4 neutropenia was seen in 4 pts (22%). G3 anemia, neutropenia and thrombocytopenia were detected in 8 (44%), 6 (33%), 4 (22%) pts, respectively. No case of febrile neutropenia occurred. Four pts (22%) developed G2 neurotoxicity. Other toxic effects were G1–2 and did not require any specific intervention. Conclusions: Administration of non-cisplatinum-based regimen seems to be of interest in elderly patients. The findings of this study confirm the efficacy and good pro- file of toxicity of weekly P–Cb in this subset of pts